A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration

NCT04063878 | Active Not Recruiting Results FDA Device

• 1 other identifier: C-OT-17-003
• Study Type: interventional
• Target: 160
• Locations: 6 countries
• Sites: 9

Brief Summary

The purpose of this study is to evaluate the outcome of prosthetic survival of the Acuris conometric concept 1 year after permanent restoration, since this is a new mode of retention using friction for seating the crown of single tooth restorations without using cement or screws.

Conditions

Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

• Prosthetic Survival

  Evaluation of presence of original permanent restoration, remained retention between abutment and final cap, and occurrence of fracture/loss of abutment. Prosthetic survival will be categorized as No/Yes. It will be categorized as "Yes" if all of the following criteria are fulfilled: * Permanent restoration is remaining in situ. * No loss of conometric retention between abutment and final cap. * No fracture of abutment. * No loss of abutment.

  1 year after permanent restoration

Secondary Outcomes (6)

• Prosthetic Survival

  3 and 5 years after permanent restoration

• Implant Survival

  1, 3 and 5 years after permanent restoration

• Marginal Bone Levels Alterations

  1, 3 and 5 years after permanent restoration

• Bleeding on Probing

  1, 3 and 5 years after permanent restoration

• Plaque

  1, 3 and 5 years after permanent restoration

Study Arms (1)

Single tooth restorations using Acuris conometric concept

EXPERIMENTAL

Device: Conometric Abutment and Conometric Final Cap

Interventions

Conometric Abutment and Conometric Final Cap DEVICE

Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.

Single tooth restorations using Acuris conometric concept

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged between 18-75 years
• Subject signed and dated the informed consent form
• In need of an implant replacing a missing tooth in position 17 to 27 or 37 to 47, and each subject can only receive one study implant.
• Neighbouring tooth to the planned implant must have
• a natural root or an implant supported restoration mesially
• a natural root or an implant supported restoration distally Exemption: If the planned implant is in the second molar position, an edentulous space is accepted distally.
• Presence of natural tooth, partial prosthesis and/or implant supported restoration in the opposite jaw in contact with the planned crown
• Deemed by the investigator as likely to present an initially stable implant situation

You may not qualify if:

• Unlikely to be able to comply with study procedures, according to Investigators judgement
• Subject is not willing to participate in the study or not able to understand the content of the study
• Involvement in the planning and conduct of the study
• Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.
• Unable or unwilling to return for follow-up visits for a period of five years
• Simultaneous participation in another clinical study, or former participation in a clinical study during the last 6 months that may interfere with the present study
• Previous enrolment in the present study
• Uncontrolled pathological process in the oral cavity
• Known or suspected current malignancy
• History of radiation therapy in the head and neck region within 12 months prior to surgery
• Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
• Uncontrolled diabetes mellitus
• Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
• Current need for major bone grafting and/or augmentation in the planned implant area (minor grafting and soft tissue grafting are allowed)
• Smoking more than 10 cigarettes per day, present alcohol or drug abuse

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (9)

University of Illinois College of Dentistry

Chicago, Illinois, 60612, United States

Location

Implant & Prosthodontic Associates

Oklahoma City, Oklahoma, 73142, United States

Location

Cholakis Dental Group

Winnipeg, Canada

Location

Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH

Ludwigshafen, Germany

Location

Studio Toia

Busto Arsizio, Italy

Location

Clínica Dental Broseta

Cheste, Spain

Location

Clinica Dental Antuña de Alaiz SL

Oviedo, Spain

Location

Ten Dental

London, United Kingdom

Location

The Implant Experts LTD

Maidstone, United Kingdom

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Dentsply IH AB d.b.a Dentsply Sirona Implants

marie.ahlson@dentsplysirona.com

+46 31 376 44 11

Study Officials

• Marco Degidi, Dr.

  Degidi Dental Clinic, Bologna, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 21, 2019
• Study Start: July 30, 2019
• Primary Completion: September 30, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 24, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1); DE (1); IT (1); ES (2); GB (2)